Kategoria BISAC: Medical >> Biostatistics

Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples.

Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set...

Praise for the first edition:

"Given the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book--not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC."

-S. T. Ounpraseuth, The American Statistician

In the first edition of this well-regarded book, the author provided a...

​​Non-parametric methods are widely used for studying populations that take on a ranked order (such as movie reviews receiving one to four stars). The use of non-parametric methods may be necessary when data have a ranking but no clear numerical interpretation, such as when assessing preferences. In terms of levels of measurement, non-parametric methods result in "ordinal" data. As non-parametric methods make fewer assumptions, their applicability is much wider than the corresponding parametric methods. In particular, they may be applied in situations where less is known about...

This book offers a collection of recent contributions and emerging ideas in the areas of robust statistics presented at the International Conference on Robust Statistics 2015 (ICORS 2015) held in Kolkata during 12 16 January, 2015. The book explores the applicability of robust methods in other non-traditional areas which includes the use of new techniques such as skew and mixture of skew distributions, scaled Bregman divergences, and multilevel functional data methods; application areas being circular data models and prediction of mortality and life expectancy. The contributions are of...

This book brings together selected peer-reviewed contributions from various research fields in statistics, and highlights the diverse approaches and analyses related to real-life phenomena.

Major topics covered in this volume include, but are not limited to, bayesian inference, likelihood approach, pseudo-likelihoods, regression, time series, and data analysis as well as applications in the life and social sciences.

The software packages used in the papers are made available by the authors.

This book is a result of the 47th Scientific Meeting of the Italian Statistical...

Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments. It explores the advantages of cluster randomisation, with special attention given to evaluating the effects of interventions against infectious diseases. Avoiding unnecessary mathematical detail, the book covers basic concepts underlying the use of cluster randomisation, such as direct, indirect, and total effects.

In the time since the publication of the first edition, the use of cluster...

Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal...

This book offers a thorough and updated guide to the theory and methods of progressive censoring, an area that has experienced tremendous growth over the last decade. Progressive censoring, originally proposed in the1950s, is an efficient method of handling samples arising from industrial experiments involving lifetimes of machines or units that have to be terminated early due to a variety of circumstances. In recent years, the theory has developed quite nicely in some special cases having practical applications to reliability and quality.

Key topics and features:

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Get Up to Speed on Many Types of Adaptive Designs

Since the publication of the first edition, there have been remarkable advances in the methodology and application of adaptive trials. Incorporating many of these new developments, Adaptive Design Theory and Implementation Using SAS and R, Second Edition offers a detailed framework to understand the use of various adaptive design methods in clinical trials.

New to the Second Edition

• Twelve new chapters covering blinded and semi-blinded sample size reestimation...

Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures.

The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO...

The book, belonging to the series "Studies in Theoretical and Applied Statistics- Selected Papers from the Statistical Societies," presents a peer-reviewed selection of contributions on relevant topics organized by the editors on the occasion of the SIS 2013 Statistical Conference "Advances in Latent Variables. Methods, Models and Applications," held at the Department of Economics and Management of the University of Brescia from June 19 to 21, 2013.

The focus of the book is on advances in statistical methods for analyses with latent variables. In fact, in recent years, there has been...

The discussed methods are illustrated with a wealth of examples, including applications ranging from stylized examples to case studies from recent literature. The...